HTLV I or Human T-cell Leukemia Virus Type I, has been identified as a causative organism for at least some forms of leukemias. This virus has been the subject of much study and has also been linked to Acquired Immune Deficiency Syndrome (AIDS). Recent studies have indicated the Type I virus is closely related to HTLV Type III virus perhaps even more closely linked to AIDS based on the work of Dr. Robert Gallo et al. of the National Cancer Institute Laboratory. Type III virus is probably the same as the LMV virus identified by the research group at the Pastuer Institute working in conjunction with the NCI; work to verify this is presently underway.
AIDS is a devastating disease wherein individuals become immunologicaly incompetent and in virtually all cases, the prognosis is certain death since at present there is no adequate treatment. Although the genesis of the disease is still the subject of much speculation, it is known that AIDS and similar virally caused conditions may be acquired by the transfusion of blood from an infected donor. Complicating the diagnosis of AIDS related diseases is the fact that these diseases are often characterized by significant incubation periods, generally on the order of two years before symptoms are expressed.
It is an object of the present invention to provide a highly diagnostic test whereby persons having such disease or having been immunologically exposed to the causative organisms may be identified and diagnosed well prior to the appearance of symptomatic conditions.
Owing to the uncertain and apparently highly infective nature of these viral organisms, research has been severely hampered by the need to take extraordinary measures to contain the virus and prevent its transmission to otherwise healthy persons. Indeed, the organism has been surrounded with such a stigma that it is very difficult and often impossible to find persons of the required caliber willing to engage in the research or manufacture of tests which employ some portion of the virus, despite its apparent deactivation.
It is a related object of the present invention to provide tests which do not rely upon deactivated virus and accordingly pose no threat for infection.
Similarly, any conventional vaccine developed utilizing deactivated virus will be difficult to manufacture. Once manufactured, it will be difficult to test due to the understandable reluctance of any volunteers. These difficulties, in combination with the long infectivity times, the infectious nature of the disease, and the present impossibility of identifying nonpreviously exposed persons or healthy "controls" will effectively prevent or unduly delay the procurement of requisite marketing approvals.
It is still another related object of the present invention to provide materials which pose no threat of infectivity but which will nonetheless be useful as vaccines.